NCT03970265

Development a Method to Extract Antibiotic Concentration From Interstitial Lung and Epithelial Lining Fluid.

Development of a Method to Extract Interstitial Lung Fluid and Epithelial Lining Fluid for Antibiotic Concentration Measurement in Explanted Lung Tissue (Feasibility Study)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Infections are critical factors for the survival of critically ill patients. A serious problem is the high variability of antibiotic concentrations in critically ill patients. This may result in the risk of underdosage with possible ineffective therapeutic levels as well as in the risk of overdosage with possible adverse and toxic effects. Essential for the effectiveness of antibiotic therapy is the antibiotic concentration at target site. The goal of this study is to establish a method to extract Interstitial Lung Fluid (ILF) and Epithelial Lining Fluid (ELF) for antibiotic concentration measurements in patients following lung Transplantation and to calculate a tissue/serum concentration ratio. Improved knowledge regarding tissue penetration of Antibiotics may help to optimize drug dosing and management.

Detailed description

Informed consent will be obtained prior to inclusion. 30 patients following lung Transplantation at the University Hospital of Munich will be included in this study. Intravenous Meropenem will be administered as perioperative antibiotic prophylaxis for lung transplantation. Interstitial Lung Fluid and Epithelial Lining Fluid will be extracted immediately after explantation of the lung from explanted lung tissue. Concentrations of antibiotics will be determined by liquid chromatography-mass spectrometry (LC-MS/MS) in ILF and ELF. Serum samples will be collected according to our in clinical routine established therapeutic drug monitoring. Tissue/Serum concentration ratio will be calculated. ELF will be collected on postoperative day 1-5 when bronchoscopy is performed during clinical routine. Numerous clinical and laboratory parameters will be determined. The investigators expect that correlations between antibiotic target site and blood concentrations and clinical and laboratory parameters will be found.

Conditions

• Lung Transplantation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	extraction of ELF and ILF from explanted lung tissue; meropenem concentration in ELF and ILF; ELF on postoperative day 1-5 when bronchoscopy is performed within clinical routine.	Interventions will only be performed on explanted lung tissue ex vivo and on supernatant of bronchoscopy and are therefore non-invasive

Timeline

• Start date: 2019-08-15
• Primary completion: 2020-07-15
• Completion: 2020-07-15
• First posted: 2019-05-31
• Last updated: 2020-09-02

Locations

1 site across 1 country: Germany